Job Description
Overview: The PM3 Operations Integration Manager will report to the Director of manufacturing and will be responsible for the establishment and management of a new manufacturing operations team. This team is required to execute the commissioning and qualification of a new isolator syringe filling line before eventually transitioning to commercial filling operations. The role will work alongside the capital projects team, the process owner team as well as the existing manufacturing organisation to deliver on these requirements. The ideal candidate will have: Five to ten years' experience within the pharmaceutical or biotech industry and will have demonstrated competency in a manufacturing people management role Direct experience with isolator syringe filling equipment is a distinct advantage Experience working in an aseptic or GMP environment in a supervisor or management position. Have the ability to influence and lead cross functional teams to deliver both tactical and strategic objectives to ensure patient supply today and into the future. Have a commitment to continuous improvement by embracing lean principles to increase the efficiency at which the department operates. A passion for embracing a culture of diversity, inclusion and belonging within our workforce to ensure Amgen remains a best place for talent. Job Scope: Production Management Ensuring Safety, Quality and Compliance Accountable for the safe operation of the area ensuring all safety policies are adhered to and that any incidents are reported and investigated in a timely manner. Promotes a positive safety culture within manufacturing. Works in a collaborative manner with other functions to ensure robust deviation investigations and assumes ownership of subsequent CAPAs to prevent reoccurrence. Contribute to and assist with Corporate, FDA, HPRA and other regulatory agencies during GMP audits and is responsible for corresponding follow up actions. Ensure the manufacturing area adheres to all relevant regulatory guidance documents. Accountable for ensuring that all staff maintains necessary training qualifications and operate in compliance with SOP's and to GMP standards. Accountable for Delivering Results by: Participate in the goal setting process for the department and manage complex goals aimed at creating competitive advantage. Supporting the shift teams by providing on the floor holiday/ absence cover, problem solving and project support. Supporting the creation of short, medium- and long-term schedules and being accountable for the on time in full execution against the plan. Ensuring that appropriate staff levels and trained resources are available at all times to meet the plan. Communicating issues and promptly escalating issues that may jeopardise manufacturing deliverables. Using project management principles to lead complex cross functional initiatives. Supporting cross functional engineering, Process development and maintenance teams to ensure right first time execution during project and commercial operation. Recognising positive performance and sharing best practices with other shifts, departments and sites within the network. Leveraging Gemba and PPoF walks to look for opportunities for improvement and recognise positive contributions. Leveraging error management and human performance tools to drive improvements in RFT performance and reduce human performance related deviations. Leading and sponsoring lean initiatives such as Kaizen events, A3 projects, 5S initiatives and CI ideas to create a culture of continuous improvement. Accountable for Communication and Escalation Strong communication skills both written and orally with the power to influence at different levels of the organisation. Providing manufacturing performance updates at various forums to audiences including senior leadership. Escalating any issues which cannot be resolved locally in accordance with Amgen's escalation policy. People management: Responsible for developing the best team by: Recruiting, interviewing, and onboarding staff to meet headcount requirements in accordance with resource models. Developing staff competencies through training, coaching and succession planning to ensure a pipeline of talent to progress through the organisation. Creating a culture of diversity, inclusion and belonging to ensure every team member feels valued at Amgen. Managing direct reports using MAP performance management systems, to ensure they meet the required performance standards, addressing issues with individuals where required to create a high performing team. Be responsible for effective management of all direct reports including people management in line with the company's disciplinary policy and standards, including active management of absenteeism, tardiness, lateness, and holidays. Basic Qualifications & Relevant Experience preferred: Typically, 5 - 10 years' experience in a GMP environment with a level of people leadership experience. Bachelor's degree in relevant science or engineering related discipline. Working knowledge of aseptic manufacturing operations Knowledge of GMP regulation requirements mainly FDA and HPRA specifically related to the manufacture of parenteral drug product. To be considered for this role you will be redirected to and must complete the application process on our careers page. 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